Methods | Between June 2002 and May 2004, 60 patients undergoing unilateral total knee arthroplasty (TKA) were enrolled in this prospective randomised trial. Randomisation was by sealed opaque envelopes which were mixed by independent personnel and consecutively assigned a case number from 1 to 60. All surgeries were performed by specialists of the joint and reconstruction team using an identical surgical approach and technique. Near the end of the operation the corresponding envelope was opened and the surgeon was informed at the time of drain insertion to achieve a single-blind effect | |
Participants | 60 patients undergoing unilateral total knee arthroplasty (TKA) were randomly allocated to one of two groups:
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Interventions |
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Outcomes | Outcomes reported: amount of allogeneic blood transfused, number of patients transfused allogeneic blood, febrile complications, adverse events, blood loss | |
Notes | Transfusion threshold: allogeneic blood transfusion was given if the haemoglobin level was less than 9.0g/dL | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Method used to generate allocation sequences was adequate. |
Allocation concealment (selection bias) | High risk | Sealed opaque envelopes were used to conceal treatment allocation |
Blinding (performance bias and detection bias) All outcomes |
High risk | Single-blind design. |